Cleared Traditional

Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle

K220204 · Anhui Tiankang Medical Technology Co., Ltd. · General Hospital
Jul 2022
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K220204 is an FDA 510(k) clearance for the Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on July 14, 2022, 170 days after receiving the submission on January 25, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K220204 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2022
Decision Date July 14, 2022
Days to Decision 170 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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